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Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy (PHOENIX)

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ClinicalTrials.gov Identifier: NCT05949593
Recruitment Status : Recruiting
First Posted : July 18, 2023
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Belite Bio, Inc

Tracking Information
First Submitted Date  ICMJE July 10, 2023
First Posted Date  ICMJE July 18, 2023
Last Update Posted Date March 19, 2024
Actual Study Start Date  ICMJE July 27, 2023
Estimated Primary Completion Date August 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2023)		 To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size [ Time Frame: From baseline to Month 24] ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2023)		 To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size [ Time Frame: From baseline to Month 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2023)
  • To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale [ Time Frame: From baseline to Month 24 ]
  • To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: From baseline to Month 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2023)
  • To measure rate of change (growth rate slope) in the aggregate area of the combined hyper- plus hypoautofluorescence lesions [ Time Frame: From baseline to Month 24 ]
  • To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale [ Time Frame: From baseline to Month 24 ]
  • To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: From baseline to Month 24 ]
  • To measure changes in mean retinal thickness by SD-OCT [ Time Frame: From baseline to Month 24 ]
  • To measure the rate of change in atrophic lesion size as determined by color fundus photography [ Time Frame: From baseline to Month 24 ]
  • To measure morphologic changes within the retinal pigment epithelium (RPE) by SD-OCT [ Time Frame: From baseline to Month 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: July 10, 2023)
  • To evaluate the correlation between the reduction of serum RBP4 and the growth of atrophic lesions (DDAF) [ Time Frame: From baseline to Month 24 ]
  • To measure changes in retinal sensitivity as assessed by microperimetry [ Time Frame: From baseline to Month 24 ]
  • To measure changes in contrast sensitivity as assessed using the Pelli-Robson Contrast Sensitivity Chart (or any assessment deemed acceptable by study sites) [ Time Frame: From baseline to Month 24 ]
 
Descriptive Information
Brief Title  ICMJE Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
Official Title  ICMJE PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)
Brief Summary This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.
Detailed Description Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)
Primary Purpose: Treatment
Condition  ICMJE Geographic Atrophy
Intervention  ICMJE
  • Drug: Tinlarebant
    5 mg tablet taken orally once a day
  • Drug: Placebo
    Placebo tablets for tinlarebant 5 mg prepared similarly.
Study Arms  ICMJE
  • Experimental: LBS-008, Tinlarebant
    Intervention: Drug: Tinlarebant
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2023)		 429
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2027
Estimated Primary Completion Date August 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
  • Minimum BCVA is required in the study eye

Exclusion Criteria:

  • The presence of diabetic macular edema or macular disease in either eye.
  • Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
  • Uncontrolled diagnosed glaucoma in the study eye
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Belitebio Clinical Operations +886 972 080 097 clinicaltrial@belitebio.com
Listed Location Countries  ICMJE Australia,   China,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05949593
Other Study ID Numbers  ICMJE LBS-008-CT05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Belite Bio, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Belite Bio, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Belite Bio, Inc
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP